Abstract Objective The objectives of this study were to, first, describe the information exchanged between pharmacy staff and patients about prescribed medication at the community pharmacy counter, and second, to investigate to what extent this met professional medication counselling guidelines. Methods Pharmaceutical encounters were videotaped in four community pharmacies in the Netherlands. Patients were included if they collected a prescription for their own use. An observation protocol, including the MEDICODE checklist, was used to analyse the video recordings. A distinction was made between first and repeat prescriptions. Key findings One hundred fifty-three encounters were videotaped. When dispensing first prescriptions, pharmacy staff provided most information on instructions how to use the medication (83.3%), form of the medication (71.4%) and treatment duration (42.9%). Topics for repeat prescriptions (such as the effects of the medication and the incidence of observed adverse effects) were rarely discussed. Pharmacy staff rarely encouraged patients to ask questions. Conclusions Pharmacy staff members provided little medication-related information at the counter, especially for repeat prescriptions, did not encourage active patient participation, and thereby did not adhere to the guidelines of their professional organisation. Further research is needed to understand the reasons for this.
Meta-analyses that use individual patient data (IPD), that is, the raw data of individual trials, rather than simply the overall results of each trial have been proposed as a major improvement in subgroup analyses. Since IPD meta-analyses often include more detailed data, they usually have greater statistical power to carry out informative subgroup analyses. By using the individual patient data the flexibility of subgroup analyses may be enhanced. Consequently, the estimated subgroup effects may be less influenced by misclassification and ecological bias. IPD meta-analyses, therefore, allow a more thorough assessment as to whether differences in treatment effects between subgroups are spurious or not. The merits of the IPD meta-analytic approach to study subgroup effects have, however, not yet been studied properly. Thus far, there is no consensus on the best methodology of analysing subgroup effects in IPD meta-analyses. The general objective of this thesis, therefore, is to study the accuracy, flexibility, and validity of IPD meta-analyses in analysing subgroup effects. The results of an extensive literature study, in which we tried to identify all published IPD meta-analyses and their related conventional meta-analyses, were used to study the methods used to study subgroups in IPD meta-analyses and to compare subgroup effect estimates of conventional and IPD meta-analyses. We showed that a wide variety of analytical methods was used in both conventional and IPD meta-analyses. We also showed that IPD meta-analyses appear to provide more relevant clinical information, since they more frequently reported subgroups based on individual patient and disease characteristics. The data of six trials (n=1,643) on the effectiveness of antibiotics in children with acute otitis media were used for several (methodological) studies. We compared the subgroup effects of 1) conventional meta-analyses using summary statistics derived from published data, 2) two-stage approach to IPD meta-analyses where summary statistics derived from IPD are used, and 3) one-stage approach to IPD meta-analyses where the IPD is pooled into a single dataset. From this study we concluded that conventional meta-analysis do not allow proper subgroup analyses, whereas IPD meta-analyses produce more accurate subgroup effects. We showed an empirical example of an IPD meta-analysis, on the (subgrouping) effects of antibiotics in preventing the development of asymptomatic middle ear effusion (MEE) in subgroups of children. We studied the influence of various methods of handling missing data (complete case analyses, single imputation within and over trials, and multiple imputations within and over trials) on the subgroup effect estimates of IPD meta-analyses. From this study we concluded that imputation within trials appears to be the most appropriate approach of handling missing data in IPD meta-analyses. We finally discussed the findings reported in this thesis and provided recommendations on how and when treatment effects in subgroups should best be analysed and reported in IPD meta-analyses. We showed that IPD meta-analyses are indeed more accurate, flexible, and valid in analysing subgroup effects, and should therefore be performed. Future studies should adhere to our recommendations regarding the analyses and report of subgroup effects in IPD meta-analyses.
What is the influence of various methods of handling missing data (complete case analyses, single imputation within and over trials, and multiple imputations within and over trials) on the subgroup effects of individual patient data meta-analyses? An empirical data set was used to compare these five methods regarding the subgroup results. Logistic regression analyses were used to determine interaction effects (regression coefficients, standard errors, and p values) between subgrouping variables and treatment. Stratified analyses were performed to determine the effects in subgroups (rate ratios, rate differences, and their 95% confidence intervals). Imputation over trials resulted in different regression coefficients and standard errors of the interaction term as compared with imputation within trials and complete case analyses. Significant interaction effects were found for complete case analyses and imputation within trials, whereas imputation over trials often showed no significant interaction effect. Imputation of missing data over trials might lead to bias, because association of covariates might differ across the included studies. Therefore, despite the gain in statistical power, imputation over trials is not recommended. In the authors' empirical example, imputation within trials appears to be the most appropriate approach of handling missing data in individual patient data meta-analyses.
Background: The Internet is increasingly considered to be an efficient medium for assessing the quality of health care seen from the patients’ perspective. Potential benefits of Internet surveys such as time efficiency, reduced effort, and lower costs should be balanced against potential weaknesses such as low response rates and accessibility for only a subset of potential participants. Combining an Internet questionnaire with a traditional paper follow-up questionnaire (mixed-mode survey) can possibly compensate for these weaknesses and provide an alternative to a postal survey.
To determine predictors of the development of asymptomatic middle ear effusion (MEE) in children with acute otitis media (AOM) and to assess the effect of antibiotic therapy in preventing the development of MEE in these children.
Data Sources
A systematic literature search was performed using PubMed, EMBASE, the Cochrane databases, and the proceedings of international otitis media symposia.
Study Selection
A trial was selected if the allocation of participants to treatment was randomized, children aged 0 to 12 years with AOM were included, the comparison was between antibiotic therapy and placebo or no (antibiotic) treatment, and MEE at 1 month was measured.
Data Extraction
Data from 5 randomized controlled trials were included in the meta-analysis of individual patient data (1328 children aged 6 months to 12 years). We identified independent predictors of the development of asymptomatic MEE and studied whether these children benefited more from antibiotic therapy than children with a lower risk. The primary outcome was MEE (defined as a type B tympanogram) at 1 month.
Data Synthesis
The overall relative risk of antibiotic therapy in preventing the development of asymptomatic MEE after 1 month was 0.9 (95% confidence interval, 0.8-1.0;P =.19). Independent predictors of the development of asymptomatic MEE were age younger than 2 years and recurrent AOM. No statistically significant interaction effects with treatment were found.
Conclusion
Because of a marginal effect of antibiotic therapy on the development of asymptomatic MEE and the known negative effects of prescribing antibiotics, including the development of antibiotic resistance and adverse effects, we do not recommend prescribing antibiotics to prevent MEE.
Objectives: Individual patient data (IPD) meta-analyses have been proposed as a major improvement in meta-analytic methods to study subgroup effects. Subgroup effects of conventional and IPD meta-analyses using identical data have not been compared. Our objective is to compare such subgroup effects using the data of six trials ( n = 1,643) on the effectiveness of antibiotics in children with acute otitis media (AOM). Methods: Effects (relative risks, risk differences [RD], and their confidence intervals [CI]) of antibiotics in subgroups of children with AOM resulting from (i) conventional meta-analysis using summary statistics derived from published data (CMA), (ii) two-stage approach to IPD meta-analysis using summary statistics derived from IPD (IPDMA-2), and (iii) one-stage approach to IPD meta-analysis where IPD is pooled into a single data set (IPDMA-1) were compared. Results: In the conventional meta-analysis, only two of the six studies were included, because only these reported on relevant subgroup effects. The conventional meta-analysis showed larger (age < 2 years) or smaller (age ≥ 2 years) subgroup effects and wider CIs than both IPD meta-analyses (age < 2 years: RD CMA -21 percent, RD IPDMA-1 -16 percent, RD IPDMA-2 -15 percent; age ≥2 years: RD CMA -5 percent, RD IPDMA-1 -11 percent, RD IPDMA-2 -11 percent). The most important reason for these discrepant results is that the two studies included in the conventional meta-analysis reported outcomes that were different both from each other and from the IPD meta-analyses. Conclusions: This empirical example shows that conventional meta-analyses do not allow proper subgroup analyses, whereas IPD meta-analyses produce more accurate subgroup effects. We also found no differences between the one- and two-stage meta-analytic approaches.
Consumer Quality Index questionnaires are used to assess quality of care from patients' experiences.To provide insight into the agreement about quality of pharmaceutical care, measured both by a patient questionnaire and video observations.Pharmaceutical encounters in four pharmacies were video-recorded. Patients completed a questionnaire based upon the Consumer Quality Index Pharmaceutical Care after the encounter containing questions about patients' experiences regarding information provision, medication counseling, and pharmacy staff's communication style. An observation protocol was used to code the recorded encounters. Agreement between video observation and patients' experiences was calculated.In total, 109 encounters were included for analysis. For the domains "medication counseling" and "communication style", agreement between patients' experiences and observations was very high (>90%). Less agreement (45%) was found for "information provision", which was rated more positive by patients compared to the observations, especially for the topic, encouragement of patients' questioning behavior.A questionnaire is useful to assess the quality of medication counseling and pharmacy staff's communication style, but might be less suitable to evaluate information provision and pharmacy staff's encouragement of patients' questioning behavior. Although patients may believe that they have received all necessary information to use their new medicine, some information on specific instructions was not addressed during the encounter. When using questionnaires to get insight into information provision, observations of encounters are very informative to validate the patient questionnaires and make necessary adjustments.
CQ-index breast care
The CQ-index breast care is a useful instrument to assess patients’ experiences with breast care. The CQ-index corresponds to an international trend, as NIVEL researchers show in their publication in the European Journal of Cancer.
Patient-centeredness has become central in many healthcare systems worldwide. Transparency is an important requirement: hospitals must be informed about their patients’ experiences to be able to improve aspects of low satisfaction. Consequently, patient satisfaction measurement has become routine in many countries. In this context, it is innovative to measure patients’ experiences (in stead of their satisfaction) and to compare these experiences with the importance patients attach to quality aspects. The Consumer Quality-index (CQ-index) is a new Dutch instrument by which patients’ experiences and their priorities can be measured. In the Netherlands, the CQ-index has become the national standard to measure patient experiences.
Quality improvement
Using the new CQ-index breast care, hospitals can assess specific quality aspects that need improvement. For example, breast cancer patients thought that information about a second opinion is very important, and they reported relatively negative experiences on that aspect. A quick appointment following referral or quickly available test results were also important to patients, but patients reported quite positive experiences in most hospitals. There is not much improvement potential on these aspects. The CQ-index informs about the relation between the importance that patients attaches to an issue and how often this aspect leads to a negative experience.
The CQ-index survey
The NIVEL regularly updates the CQ-index surveys. Hospitals that want to use the survey can download it from the website of the Centre for Consumer Experience in Healthcare. In addition to hospitals, other parties such as health Insurance companies and patient organisations can use the survey.
